Investigation of Allocetra in Critical COVID-19 Patients

Impact of COVID-19 on Global Health

The COVID-19 pandemic has significantly affected individuals worldwide. While most recover from SARS-CoV-2 with minimal symptoms, a subset of patients experiences severe complications. These complications can include cardiovascular problems, severe shortness of breath, organ failure, and other issues necessitating hospital care.

Current Treatments for Hospitalized COVID-19 Patients

In hospital settings, several treatments are available for COVID-19 patients. Notable options include corticosteroids like dexamethasone and antiviral medications such as remdesivir.

Cytokine Storms in Critical Patients

A serious complication known as cytokine storms can occur in critically ill COVID-19 patients. This phenomenon arises when cytokines—molecules that prompt inflammatory responses—become overly active, leading to the immune system attacking healthy cells. Such reactions can cause life-threatening complications, including organ dysfunction and failure. Cytokine storms are not unique to COVID-19; they are also linked to conditions like sepsis and complications from some immunotherapies.

Role of Allocetra in Preventing Cytokine Storms

According to Enlivex Therapeutics Ltd., the manufacturer of Allocetra, this treatment is designed to prevent cytokine storms by regulating cytokine activity and reprogramming dysfunctional macrophages. Previous research has suggested that Allocetra may effectively treat cytokine storms associated with sepsis. In a study published in Cytotherapy involving ten critically ill sepsis patients treated with Allocetra, all participants recovered within 28 days, demonstrating a zero percent mortality rate and no severe side effects.

Recent Clinical Trial of Allocetra for COVID-19

The most recent research on Allocetra involved a phase II clinical trial conducted in November and December, which included eight COVID-19 patients. Among these, two were critically ill while the others were in severe condition. Following treatment with Allocetra, seven of the eight participants experienced complete recovery and were discharged from the hospital within an average of 4.7 days. Notably, one critically ill patient showed significant improvement, with their condition reclassified as moderate/severe as of December 3, 2020. No serious side effects were reported among the participants.

Conclusion and Future Research Directions

The findings from this phase II study indicate that Allocetra could be a viable treatment option for patients facing cytokine storms due to COVID-19 complications. However, further research is necessary to fully understand its effectiveness, mechanisms, and potential side effects. Enlivex has indicated that additional studies on Allocetra for COVID-19 are planned for 2021.

References

– BMJ Best Practice (2021). BMJ Publishing Group. Accessed February 15, 2021, from https://bestpractice.bmj.com/topics/en-us/3000168/complications
– Clinical Reference Group Recommendations: Therapies for COVID-19 (January 29, 2021). BC Centre for Disease Control. Accessed February 15, 2021, from http://www.bccdc.ca/health-professionals/clinical-resources/covid-19-care/clinical-care/treatments
– Cunha, J.P. (March 30, 2020). RxList Consumer. Accessed February 15, 2021, from https://www.rxlist.com/consumer_remdesivir_rdv/drugs-condition.htm
– Enlivex (December 3, 2020). Enlivex Therapeutics Ltd. Accessed February 15, 2021, from https://enlivex.com/pipeline/covid-19/.
– Giles, A.J., Hutchinson, M.N.D., Sonnemann, H.M., et al. (2018). Dexamethasone-induced immunosuppression: mechanisms and implications for immunotherapy. Journal for ImmunoTherapy of Cancer 6(51). Doi: 10.1186/s40425-018-0371-5.
– Hess, S. (June 2019). Life-saving immunomodulating cell therapies [Enlivex presentation]. Accessed February 15, 2021, from https://www.jefferies.com/CMSFiles/Jefferies.com/files/Enlivex.pdf
– Mevorach, D. (May 2020). Effect of Allocetra-OTS (off-the-shelf apoptotic cells) Therapy in Sepsis. Cytotherapy 22(5). Doi: 10.1016/j.cyt.2020.03.488.